Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group (MIRAS)
Primary Purpose
Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient with Soft Tissue Sarcoma
Sponsored by
About this trial
This is an interventional other trial for Soft Tissue Sarcoma focused on measuring Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors, Alveolar Soft Part Sarcoma, Epithelioid Hemangioendothelioma, Low Grade Fibromyxoid Sarcoma, Sclerosing Epithelioid Fibrosarcoma
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years at the time of study entry.
Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:
- Clear Cell Sarcoma (CCS)
- Epithelioid Sarcoma (ES)
- Perivascular Epithelioid Cell neoplasm (PEComa)
- Desmoplastic Small Round Cell Tumours (DSRCT)
- Malignant Solitary Fibrous Tumours (mSFT)
- Alveolar Soft Part Sarcoma (ASPS)
- Epithelioid Hemangioendothelioma (EH)
- Low-Grade Fibromyxoid Sarcoma (LGFS)
- Sclerosing Epithelioid Fibrosarcoma (SEF).
- Localized/locally advanced or metastatic disease.
- In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
- In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
- Patient followed in the center within a standard of care procedure or clinical trial.
- Archived tumor specimen at initial diagnosis available (before treatment initiation).
- Evaluable disease (measurable as per RECIST 1.1) or not.
- ECOG Performance status 0-3.
- Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
- Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
- Diagnosis of all other histotypes of soft tissue sarcoma.
- Any condition contraindicated with procedures required by the protocol.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Pregnant or breast-feeding woman.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Sites / Locations
- Chu Besancon - Site Jean MinjozRecruiting
- Centre Jean PerrinRecruiting
- Centre Oscar LambretRecruiting
- Chu DupuytrenRecruiting
- Centre Leon BerardRecruiting
- Institut Paoli-Calmettes
- Chu de Marseille - Hopital de La TimoneRecruiting
- Centre Antoine LacassagneRecruiting
- Hôpital Cochin - Site Port-RoyalRecruiting
- Institut CurieRecruiting
- Chu PoitiersRecruiting
- Institut GodinotRecruiting
- Centre Eugene MarquisRecruiting
- Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
- Institut de Cancérologie Strasbourg EuropeRecruiting
- Institut Universitaire du Cancer Toulouse - OncopoleRecruiting
- Institut de Cancerologie de LorraineRecruiting
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with Soft Tissue Sarcoma (Prospective cohort)
Arm Description
Outcomes
Primary Outcome Measures
Metastasis-free survival for patients with localized disease.
Progression-free survival for patients with metastatic disease.
Secondary Outcome Measures
Cancer-Testis Antigens (CTA) expression.
The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.
Overall survival.
Full Information
NCT ID
NCT03967834
First Posted
May 27, 2019
Last Updated
September 22, 2023
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT03967834
Brief Title
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
Acronym
MIRAS
Official Title
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 2031 (Anticipated)
Study Completion Date
April 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.
400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.
Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors, Alveolar Soft Part Sarcoma, Epithelioid Hemangioendothelioma, Low Grade Fibromyxoid Sarcoma, Sclerosing Epithelioid Fibrosarcoma
Keywords
Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors, Alveolar Soft Part Sarcoma, Epithelioid Hemangioendothelioma, Low Grade Fibromyxoid Sarcoma, Sclerosing Epithelioid Fibrosarcoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with Soft Tissue Sarcoma (Prospective cohort)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Patient with Soft Tissue Sarcoma
Intervention Description
Tumor specimens will be collected for the study at diagnosis.
A blood sample will be collected in all included patients at baseline, after the completion of the treatment (for patients included with a localized disease) or at the time of the first tumoral evaluation (for patients included with a metastatic disease), and at the time of progression.
Patient's data (clinical, biological and disease data) will also be collected at baseline visit and then at each time point planned in the center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years.
Primary Outcome Measure Information:
Title
Metastasis-free survival for patients with localized disease.
Time Frame
60 months for each patients
Title
Progression-free survival for patients with metastatic disease.
Time Frame
60 months for each patients
Secondary Outcome Measure Information:
Title
Cancer-Testis Antigens (CTA) expression.
Time Frame
60 months for each patients
Title
The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.
Time Frame
60 months for each patients
Title
Overall survival.
Time Frame
60 months for each patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at the time of study entry.
Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:
Clear Cell Sarcoma (CCS)
Epithelioid Sarcoma (ES)
Perivascular Epithelioid Cell neoplasm (PEComa)
Desmoplastic Small Round Cell Tumours (DSRCT)
Malignant Solitary Fibrous Tumours (mSFT)
Alveolar Soft Part Sarcoma (ASPS)
Epithelioid Hemangioendothelioma (EH)
Low-Grade Fibromyxoid Sarcoma (LGFS)
Sclerosing Epithelioid Fibrosarcoma (SEF).
Localized/locally advanced or metastatic disease.
In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
Patient followed in the center within a standard of care procedure or clinical trial.
Archived tumor specimen at initial diagnosis available (before treatment initiation).
Evaluable disease (measurable as per RECIST 1.1) or not.
ECOG Performance status 0-3.
Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
Diagnosis of all other histotypes of soft tissue sarcoma.
Any condition contraindicated with procedures required by the protocol.
Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Pregnant or breast-feeding woman.
Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaud VALENTIN
Phone
+33 (0)5 31 15 51 70
Email
Valentin.Thibaud@iuct-oncopole.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric CHIBON
Phone
+33 (0)5 82 74 17 65
Email
frederic.chibon@inserm.fr
Facility Information:
Facility Name
Chu Besancon - Site Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MEYNARD
Phone
03 70 63 24 03
Email
gmeynard@chu-besancon.fr
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale DUBRAY-LONGERAS
Phone
04 73 27 81 41
Email
pascale.dubray-longeras@clermont.unicancer.fr
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc LEBELLEC
Phone
03 20 29 59 59
Email
l-lebellec@o-lambret.fr
Facility Name
Chu Dupuytren
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie LE BRUN-LY
Phone
05 55 05 61 00
Email
valerie.lebrunly@chu-limoges.fr
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armelle DUFRESNE
Phone
04 69 85 61 47
Email
armelle.dufresne@lyon.unicancer.fr
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BERTUCCI
Phone
04 91 22 35 37
Email
bertuccif@ipc.unicancer.fr
Facility Name
Chu de Marseille - Hopital de La Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien SALAS
Phone
04 91 38 57 08
Email
sebastien.salas@ap-hm.fr
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esma SAADA-BOUZID
Phone
04 92 03 15 14
Email
esma.saada-bouzid@nice.unicancer.fr
Facility Name
Hôpital Cochin - Site Port-Royal
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascaline BOUDOU-ROUQUETTE
Phone
01 58 41 14 39
Email
pascaline.boudou@aphp.fr
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah WATSON
Email
sarah.watson@curie.fr
Facility Name
Chu Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas ISAMBERT
Phone
05 49 44 45 48
Email
nicolas.isambert@chu-poitiers.fr
Facility Name
Institut Godinot
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SOIBINET-OUDOT Pauline
Phone
03 26 50 43 83
Email
pauline.soibinet@reims.unicancer.fr
Facility Name
Centre Eugene Marquis
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angélique BRUNOT
Phone
02 99 25 32 80
Email
a.brunot@rennes.unicancer.fr
Facility Name
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BOMPAS
Phone
02 40 67 99 39
Email
emmanuelle.bompas@ico.unicancer.fr
Facility Name
Institut de Cancérologie Strasbourg Europe
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine GANTZER
Phone
03 68 76 72 25
Email
j.gantzer@icans.eu
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud VALENTIN
Phone
+33 (0)5 31 15 51 70
Email
Valentin.Thibaud@iuct-oncopole.fr
Facility Name
Institut de Cancerologie de Lorraine
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria RIOS
Phone
03 83 59 84 61
Email
m.rios@nancy.unicancer.fr
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Learn more about this trial
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
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